Verona Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update

Verona Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update

Positive Phase 2 results with pMDI ensifentrine in COPD

Enrollment ongoing in ENHANCE Phase 3 program

 Up to $30 million debt finance facility increases financial flexibility

Conference call today at 9:00 a.m. EST / 2:00 p.m. GMT

LONDON and RALEIGH, N.C., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its financial results for the fourth quarter and full year ended December 31, 2020, and provides a corporate update.

“2020 was a transformative year for Verona Pharma,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. "We started the year with positive data from a Phase 2b trial where nebulized ensifentrine demonstrated clinically meaningful improvements in lung function and quality of life measures when added-on to single bronchodilator therapy. In May, we received End-of-Phase 2 guidance from the U.S. Food and Drug Administration on the design of our Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) clinical development program and, in September, we began enrollment. This progress was made possible by strong support from the investment community through our $200 million private placement completed in July.

“2021 is already off to a great start with the recently announced positive Phase 2 clinical results with the pMDI formulation of ensifentrine in moderate to severe COPD patients. We anticipate top-line data from the pilot COVID-19 study of ensifentrine in the second quarter of 2021. In addition, patient enrollment in the ENHANCE program is ongoing and we expect to complete enrollment in both studies in the second half of 2021. Based on our recruitment projections, top-line data from ENHANCE-2 is expected in the first half of 2022 and from ENHANCE-1 in the second half of 2022.”

Fourth Quarter and Recent Highlights

Clinical

• In February 2021, Verona Pharma announced positive Phase 2 efficacy and safety data with pMDI ensifentrine in patients with moderate to severe COPD. The primary and secondary lung function endpoints were achieved and the data support twice-daily dosing.
• In January 2021, the Company completed enrollment of 45 patients in its pilot clinical study evaluating the efficacy and safety of pMDI ensifentrine in U.S. patients hospitalized with COVID-19. Top-line results are expected in the second quarter of 2021.
• In October 2020, the Company presented favorable symptom and quality of life data from a Phase 2b clinical trial with nebulized ensifentrine in COPD at CHEST Annual Meeting 2020. The posters highlighted ensifentrine’s potential to provide rapid benefits to symptomatic patients.

Financial

• In November 2020, the Company entered into a debt financing facility for up to $30 million with Silicon Valley Bank. The non-dilutive capital provides further financial flexibility to support pre-commercialization activities for ensifentrine.
• In October 2020, Verona Pharma delisted from the AIM Market of the London Stock Exchange in an effort to enhance liquidity of trading by combining all transactions on the Nasdaq Global Market (“Nasdaq”) and to reduce costs through removing duplicative listing and compliance fees. The Company’s American Depositary Shares remain publicly traded on Nasdaq.

Upcoming Key Milestones

The Company’s near-term milestones include:

• Reporting top-line data from a pilot clinical study evaluating the pMDI formulation of ensifentrine in U.S. patients hospitalized with COVID-19 in the second quarter of 2021.
• Based on recruitment projections, the Company expects to complete enrollment in both Phase 3 trials, ENHANCE-1 and ENHANCE-2, with the nebulized formulation of ensifentrine for the maintenance treatment of COPD in the second half of 2021.
• Longer term, based on forecasted recruitment, the Company expects to announce top-line data from ENHANCE-2 in the first half of 2022 and ENHANCE-1 in the second half of 2022.

Fourth Quarter and Full Year 2020 Financial Results

• Cash position: Cash, cash equivalents and short term investments at December 31, 2020, were $188.0 million (December 31, 2019: $40.8 million). We believe our cash and cash equivalents at December 31, 2020, together with funding expected to become available under the $30.0 million debt financing facility secured in November and from cash receipts from U.K. tax credits, will enable us to fund our planned operating expenses and capital expenditure requirements into 2023.
• R&D Expenses: Research and development (“R&D”) expenses were $16.4 million for the fourth quarter ended December 31, 2020 (Q4 2019: $7.2 million) and $44.5 million for the year ended December 31, 2020 (full year 2019: $42.4 million). The increase of $2.1 million was primarily attributable to an increase in share-based compensation charges and salary and related costs as we expanded the clinical development team.
• G&A Expenses: General and administrative expenses (“G&A”) were $11.3 million for the fourth quarter ended December 31, 2020 (Q4 2019: G&A expenses $2.3 million) and $29.8 million for the year ended December 31, 2020 (full year 2019: G&A expenses $10.0 million), an increase of $19.8 million. This increase was primarily due to share-based compensation charges, severance costs, salaries, higher Director and Officers insurance premiums and costs related to the private placement.
• Net loss: Net loss was $24.8 million for the fourth quarter ended December 31, 2020 (Q4 2019: net loss $9.5 million) and $65.1 million for the year ended December 31, 2020 (full year 2019: net loss $40.6 million).

Conference Call and Webcast Information

Verona Pharma will host an investment community conference call at 9:00 a.m. EST/2:00 p.m. GMT on Thursday, February 25, 2021 to discuss the fourth quarter and full year 2020 financial results and the corporate update.

Analysts and investors may participate by dialing one of the following numbers and reference conference number: 7681320:

• +1-888-317-6003 for callers in the United States
• +1-412-317-6061 for international callers

A live webcast will be available on the Events and Presentations link on the Investors page of the Company's website, www.veronapharma.com, and an audio replay will be available there for 30 days. An electronic copy of the fourth quarter and full year 2020 results release will also be made available today on the Company’s website. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

For further information please contact: